UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051258 |
|---|---|
| Receipt number | R000058458 |
| Scientific Title | Axial Length Acquisition Rate of ARGOS compared to ANTERION in the dense cataract eyes |
| Date of disclosure of the study information | 2023/06/05 |
| Last modified on | 2023/06/05 10:57:37 |
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Basic information
Public title
Axial Length Acquisition Rate of 2 Biometers in the dense cataract eyes
Acronym
Comparison of Axial Length Acquisition Rate
Scientific Title
Axial Length Acquisition Rate of ARGOS compared to ANTERION in the dense cataract eyes
Scientific Title:Acronym
Comparison of Axial Length Acquisition Rate
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate axial length acquisition rate of ARGOS compared to ANTERION in the eyes with nuclear hardness glade 4 or higher of Emery-Little classification(G4).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Axial length acquisition success rate in the eyes with nuclear hardness G4 or higher
Key secondary outcomes
Axial length acquisition success rate in all eyes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients with the age between 50 and 90 years
2.Patients undergoing age-related cataract surgery by phacoemulsification at cyukyo eye clinic
3.Patients with AcrySof IQ IOL inserted in the capsular bag
4.Patients measured by ARGOS and Anterion before and after cataract surgery
Key exclusion criteria
1.Patients who could not be fixation
2.Disqualified by the investigator or the sub investigator because of systemic or ophthalmic diseases
Target sample size
235
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi , Japan
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi , Japan
TEL
052-883-1543
Homepage URL
ichikawa@chukyogroup.jp
Sponsor or person
Institute
Chukyo Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Alcon Japan Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chukyo Eye Clinic REC
Address
12-23 Sanbonmatsu-cho, Atsuta-ku, Nagoya, Aichi , Japan
Tel
052-884-7976
rec@chukyogroup.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate axial length acquisition rate of ARGOS compared to ANTERION in the eyes with nuclear hardness glade 4 or higher of Emery-Little classification(G4).
Management information
Registered date
| 2023 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058458
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
